Vertex Pharmaceuticals

Engineer

• Responsible for the day-to-day administration of the Vertex data classification and protection systems
• Consult with members of the technical and business communities to identify and label Vertex data
• Analyze and resolve complex software and hardware problems
• Ensure correct processes are followed in change management for tracking and reproducibility
• Create training materials to expand the adoption of identifying and labeling data using Microsoft 365 Sensitivity Labels
• Independently create data usage reports and integrate new sources of Vertex data

Data Classification Engineer – Identity Management

Business Analyst

• Document system requirements based on input from key business partners, superusers and technical leads.
• Work with functional area stakeholders to assess and prioritize system enhancements and business needs related to technology and process optimization.
• Provide oversight and support to DTE and validation team during requirements definition, systems and process design, data migration, data cleansing and user acceptance testing activities.
• Contribute to communication to and education of users on business tools and the functional impact to workflows and processes, including oversight and development of training content, formal business guidelines and reference material.

Regulatory Business Analyst – Contract

Compliance

• Support data mapping of eCTD metadata from legacy publishing system into future state system
• Support activities in preparation of enabling eCTD 4.0 submissions
• Work mostly conducted in Excel, working against data extracts from Veeva Vault RIM
• Own portions of the data migration mapping to enable Veeva Publishing as well as preparation activities for eCTD 4.0 enablement, including, but not limited to:
• Mapping legacy eCTD metadata into Veeva RIM relationships
• Identifying out of date eCTD relationships
• Suggesting updates to align with historical dossiers and enable future lifecycle management
• Corrections to the Veeva RIM archive as needed
• Mapping of current submission types and subtypes against Veeva and HA recommended nomenclature
• Mapping of existing submission records and fields into updated data models and fields
• Mapping eCTD 4.0 functionality in Veeva Publishing and executing end user testing as needed

Data Classification Engineer – Identity Management

Regulatory Business Analyst – Contract

eCTD Publishing Manager, Regulatory Affairs – Contract